Onychomycosis
Conditions
Keywords
onychomycosis
Brief summary
The efficacy and safety of ENRICHED (X92001591) will be evaluated in a multicentric, randomized, evaluator blinded clinical investigation in 88 patients.
Detailed description
Subjects will be treated with either the test medical device (ENRICHED X92001591) or the reference product (Loceryl, 5% amorolfine) for a period of 9 months. The primary objective of the investigation will be increase of % of healthy nail surface versus baseline, as evaluated by a blinded investigator. Subjects will be followed up for a period of 9 months, with visits at D0 (baseline), D90 (month 3), D180 (month 6) and D270 (month 9).
Interventions
DEVICEEnriched
To be used twice a day
DRUGLoceryl 5%
To be used once a week
Sponsors
Eurofins Dermscan Pharmascan
Oystershell NV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The primary objective is to evaluate the effectiveness of Enriched and Loceryl® in the treatment of onychomycosis based on the blinded evaluation of the percentage of healthy nail surface compared to baseline
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Patient having given freely her/his informed, written consent. 2. Patient having a good general health. 3. Age: between 18 and 70 years; 4. Patient with superficial onychomycosis on at least one great toenail or fingernail (for at least 10% in each arm) or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement <2/3 of the tablets). 5\. Patient with positive KOH staining. 6. Patient cooperative and aware of the products modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected. 7\. Patient being psychologically able to understand information and to give their/his/her consent. 8\. Patient having stopped any systemic antifungal treatment since at least 6 months before screening and/or any topical antifungal treatment since at least 3 months before screening. 9\. Patient who agree to refrain from receiving pedicure/manicure, artificial nails and/or cosmetic nail varnish or other medication on the nail being treated for the entire study duration. 10\. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after study end.
Exclusion criteria
\- 1. Pregnant, breastfeeding woman or woman planning a pregnancy during the study; 2. Patient considered by the investigator likely to be non-compliant with the protocol. 3. Patient enrolled in another clinical trial or which exclusion period is not over. 4. Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk; 5. Patient suffering from a severe or progressive disease (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology… 6. Patient having a known allergy or hypersensitivity to one of the constituents of the tested products. 7\. Patient with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blinded evaluation of the percentage of healthy nail surface | 270 days | Variation of the percentage of healthy surface after 270 days (9 months) of treatment with the test medical device or reference product versus baseline value. Blinded evaluation is done by digital analysis of photographs of the infected toenail or fingernail. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of healthy surface (performance) | 90 days, 180 days | Variation of the percentage of healthy surface after 90 days (3 months) and 180 days (6 months) of treatment with the test medical device or reference product versus baseline value. Blinded evaluation is done by digital analysis of photographs of the infected toenail or fingernail. |
| Mirobiological efficacy ; KOH staining (Performance) | 270 days | Evaluation of microbiological efficacy of both treatments versus baseline by KOH staining and fungal culture at D270 (month 9) |
| Clinical efficacy: Visual appearance of nail (including onycholysis, nail dystrophy, nail discoloration and nail thickening) (Performance) | 90 days, 180 days, 270 days | Assessment of clinical efficacy of both treatments on D0 (baseline), D90 (month 3), D180 (month 6) and D270 (month 9) by evaluation of the following parameters: onycholysis, nail dystrophy, nail discoloration, and nail thickening by the investigator in live. Each parameter is scored from 0 (none) - 4 (severe). The total score of all parameters is an indication of the visual appearance of the nail. |
| Impact on quality of life (Performance) | 180 days, 270 days | Evaluation of the impact on the quality of life (QoL) of patients using a validated questionnaire (NailQoL) on D0 (baseline) and 180 (month 6) and 270 (month 9) days of treatment with the test medical device or reference, respectively |
| Subjective evaluation questionnaire for the patient (Performance) | 14 days, 90 days, 180 days, 270 days | Evaluation of efficacy, tolerance, and acceptability of the test medical device and reference by thepatients using a subjective evaluation questionnaire, performed at D14, D90 (month 3), D180 (month 6) and D270 (month 9). |
| Evaluation of tolerance | 90 days, 180 days, 270 days | Evaluation of tolerance of the test medical device and reference product at D90 (month 3), D180 (month 6) and D270 (month 9). Assessment is performed by the investigator via clinical evaluation and subject interrogation. The investigator will assign a score between 0 (bad tolerance) to 3 (very good tolerance). |
| Clinical efficacy: onychomycosis evolution (Performance) | 90 days, 180 days, 270 days | Assessment of onychomycosis evolution on D90 (month 3), D180 (month 6) and D270 (month 9) by the investigator in live * Failure: increase in the total infected area or aggravation * Status Quo * Improvement: decrease of the total infected area * Success: Disappearance of the total infected area |
Countries
France
Contacts
Primary ContactManon Laune, Project manager
Outcome results
None listed